UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) of the SECURITIES EXCHANGE ACT OF
1934
Date
of Report (Date of earliest event reported): December 8, 2017
VistaGen Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
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NEVADA
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001-37761
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20-5093315
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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(IRS Employer Identification Number)
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343 Allerton Ave.
South San Francisco, California 94090
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(Address of principal executive offices)
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(650)
577-3600
(Registrant’s telephone number, including area
code)
Not Applicable
(Former name or former address, if changed since last
report)
Check the
appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant
under any of the following provisions (see General Instruction A.2.
below):
☐
Written
communications pursuant to Rule 425 under the Securities Act (17
CFR 230.425)
☐
Soliciting material
pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
☐
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR 240.14d-2(b))
☐
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR 240.13e-4(c))
Indicate by check mark whether the registrant is
an emerging growth company as defined in Rule 405 of the Securities
Act of 1933 (17 CFR 230.405) or Rule 12b-2 of the Securities
Exchange Act of 1934 (17 CFR 240.12b-2) ☐
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended
transition period for complying with any new or revised financial
accounting standards provided pursuant to Section 13(a) of the
Exchange Act ☐
Item 8.01
Other
Events.
On December
8, 2017, VistaGen Therapeutics, Inc. (the
“Company”)
announced that the U.S. Patent and Trademark Office
(“USPTO”) issued new U.S. Patent No.
9,834,754 related to methods for producing, from human pluripotent stem
cells (hPSCs), hematopoietic precursor stem cells with the
potential to impact both direct and supportive therapy for
autoimmune disorders and cancer, with CAR-T cell applications and
foundational technology which may provide approaches for producing
bone marrow stem cells for bone marrow transfusions. VistaGen holds
an exclusive license to this newly issued U.S. patent from the
University Health Network in Toronto. A copy of the press release
is attached to this Current Report on Form 8-K as Exhibit 99.1, and
is incorporated herein by reference.
Item 9.01
Financial Statements and
Exhibits.
See
Exhibit Index.
SIGNATURES
Pursuant to the
requirements of the Securities Exchange Act of 1934, the registrant
has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
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VistaGen
Therapeutics, Inc.
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Date:
December 8, 2017
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By:
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/s/ Shawn K. Singh
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Shawn K.
Singh
Chief Executive
Officer
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EXHIBIT INDEX
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Exhibit
No.
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Description
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99.1
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Press release
issued by VistaGen Therapeutics Inc., dated December 8,
2017.
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Exhibit
99.1
VistaGen
Therapeutics Expands Stem Cell Patent Portfolio with New U.S.
Patent
on Methods for
Producing Blood Cells, Platelets and Bone Marrow Stem
Cells
with Potential
to Treat Autoimmune Disorders and Cancer
SOUTH SAN FRANCISCO,
CA--(Marketwired - December 08, 2017) - VistaGen
Therapeutics Inc. (VTGN), a clinical-stage biopharmaceutical
company focused on developing new generation medicines for
depression and other central nervous system (CNS) disorders,
announced today that the U.S. Patent and Trademark Office (USPTO)
has issued U.S. Patent No. 9,834,754 related to methods for
producing, from human pluripotent stem cells (hPSCs), hematopoietic
precursor stem cells, which are stem cells that give rise to all of
the blood cells and most of the bone marrow cells in the body.
VistaGen holds an exclusive license to this patent from the
University Health Network (UHN).
The technology covered by the issued U.S. patent has the potential
to impact both direct and supportive therapy for autoimmune
disorders and cancer, with CAR-T cell applications, and
foundational technology which may provide approaches for producing
bone marrow stem cells for bone marrow transfusions.
Dr. Gordon Keller, Director of the McEwen Centre for Regenerative
Medicine in Toronto, one of the world's leading centers for stem
cell and regenerative medicine research and part of the University
Health Network (UHN), discovered the stem cell technology covered
by this patent.
About
VistaGen
VistaGen Therapeutics, Inc. (VTGN) is a clinical-stage
biopharmaceutical company focused on developing new generation
medicines for depression and other CNS disorders. VistaGen's lead
CNS product candidate, AV-101, is in Phase 2 development, initially
as a new generation oral antidepressant drug candidate for major
depressive disorder (MDD). AV-101's mechanism of action is
fundamentally different from all FDA-approved antidepressants and
atypical antipsychotics used adjunctively to treat MDD, with
potential to drive a paradigm shift towards a new generation of
safer and faster-acting antidepressants. AV-101 is currently being
evaluated by the National Institute of Mental Health (NIMH) in a
small Phase 2 monotherapy study in MDD being fully funded by the
NIMH and conducted by Dr. Carlos Zarate Jr., Chief, Section on the
Neurobiology and Treatment of Mood Disorders and Chief of
Experimental Therapeutics and Pathophysiology Branch at the NIMH.
VistaGen is preparing to launch a 180-patient Phase 2 study of
AV-101 as an adjunctive treatment for MDD patients with an
inadequate response to standard, FDA-approved antidepressants, with
Dr. Maurizio Fava of Harvard University as Principal Investigator.
AV-101 may also have the potential to treat multiple CNS disorders
and neurodegenerative diseases in addition to MDD, including
neuropathic pain, epilepsy, Huntington's disease, Parkinson's
disease levodopa-induced dyskinesia and other disorders where
modulation of the NMDA receptors, activation of the AMPA
neurotransmitter pathways and/or key active metabolites of AV-101
may achieve therapeutic benefit.
For more information, please visit www.vistagen.com and connect
with VistaGen on Twitter, LinkedIn and Facebook.
Forward-Looking
Statements
The statements in this press release that are not historical facts
may constitute forward-looking statements that are based on current
expectations and are subject to risks and uncertainties that could
cause actual future results to differ materially from those
expressed or implied by such statements. Those risks and
uncertainties include, but are not limited to, risks related to
securing sufficient funding for, and the launch, continuation and
results of the NIMH's Phase 2 (monotherapy) and/or the Company's
planned Phase 2 (adjunctive treatment) clinical studies of AV-101
in MDD, and other CNS diseases and disorders, including neuropathic
pain and PD LID, allowance of patent applications and continued
protection of its intellectual property, and the availability of
substantial additional capital to support its operations, including
the AV-101 Phase 2 adjunctive treatment study and other potential
AV-101 clinical development activities described above. These and
other risks and uncertainties are identified and described in more
detail in VistaGen's filings with the Securities and Exchange
Commission (SEC). These filings are available on the SEC's website
at www.sec.gov. VistaGen undertakes no obligation to publicly
update or revise any forward-looking statements.
Company Contact
Mark
A. McPartland
VistaGen
Therapeutics Inc.
Phone:
+1 (650) 577-3600
Email: IR@vistagen.com
Investor Contact:
Valter
Pinto / Allison Soss
KCSA
Strategic Communications
Phone:
+1 (212) 896-1254/+1 (212) 896-1267
Email:
VistaGen@KCSA.com